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CTRI Number  CTRI/2025/09/095437 [Registered on: 26/09/2025] Trial Registered Prospectively
Last Modified On: 26/09/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Development of a Physiotherapy protocol to address pelvic floor disorders in Postpartum Women 
Scientific Title of Study   Development of a Comprehensive Physiotherapy Protocol for Obstetric Pelvic Floor Disorder in Postpartum Women: A Mixed-Method Study Design 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Kirti Jadhav 
Designation  Associate Professor 
Affiliation  School of Physiotherapy, D.Y.Patil Deemed to be University 
Address  Department of Physiotherapy in Community Health, School of Physiotherapy, 6th Floor, School of Medicine Building, D.Y. Patil Deemed to be University, Sector 5, Nerul-East, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9004823854  
Fax    
Email  kirti.jadhav@dypatil.edu  
 
Details of Contact Person
Scientific Query
 
Name  Kirti Jadhav 
Designation  Associate Professor 
Affiliation  School of Physiotherapy, D.Y.Patil Deemed to be University 
Address  Department of Physiotherapy in Community Health, School of Physiotherapy, 6th Floor, School of Medicine Building, D.Y. Patil Deemed to be University, Sector 5, Nerul-East, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  9004823854  
Fax    
Email  kirti.jadhav@dypatil.edu  
 
Details of Contact Person
Public Query
 
Name  Dr Anu Arora 
Designation  Professor 
Affiliation  School of Physiotherapy, D.Y.Patil Deemed to be University 
Address  Department of Physiotherapy in Community Health, School of Physiotherapy, 6th Floor, School of Medicine Building, D.Y. Patil Deemed to be University, Sector 5, Nerul-East, Navi Mumbai

Thane
MAHARASHTRA
400706
India 
Phone  8452842895  
Fax    
Email  anu.arora@dypatil.edu  
 
Source of Monetary or Material Support  
D.Y. Patil Hospital and Reasearch Centre, Navi Mumbai 
 
Primary Sponsor  
Name  NIL 
Address  NA 
Type of Sponsor  Other [NIL] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anu Arora  D. Y. Patil Hospital and Reseacrh Centre  Physiotherapy Department, OPD No. 29, D.Y. Patil Hospital and Research centre Sector-5, Nerul East, Navi Mumbai
Thane
MAHARASHTRA 
84525842895

anu.arora@dypatil.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical and Health Research (IECBH)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O269||Pregnancy related conditions, unspecified, (2) ICD-10 Condition: O348||Maternal care for other abnormalities of pelvic organs, (3) ICD-10 Condition: N949||Unspecified condition associated with female genital organs and menstrual cycle,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Comprehensive Physiotherapy Protocol for Obstetric Pelvic Floor Disorders  A Physiotherapy protocol will be administered to the postpartum women with Obstetric Pelvic Floor Disorders. This protocol will include exercises, Electrical stimulation, Manual therapy techniques etc. as per the findings obtained in the evaluation. 
Comparator Agent  Pelvic Physiotherapy Standard of care protocol  Kegels exercises and ergonomic advices 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Women in the age group of 18-40 years and within 1 year of childbirth.
Women who have reported symptoms of obstetric pelvic floor disorder
 
 
ExclusionCriteria 
Details  Women with symptoms of pelvic floor dysfunction before pregnancy
Women with recent abdominal or pelvic surgery, apart from LSCS in the past 1 year
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Symptoms of Obstetric Pelvic Floor Disorders
Quality of life 
At baseline and at 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/10/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

INTRODUCTION & BACKGROUND:

Postpartum period refers to the period that begins upon the delivery of the infant to 12 months after the delivery. [1] Pregnancy and childbirth bring along several changes to a woman’s body, especially to the musculoskeletal system – mainly pelvic floor.[2,3] The primary reasons for these adaptations include weight of the gravid uterus, Changes in intra-abdominal pressure[4] Changes in intra-abdominal pressure [5,6] and strains during labor. [7,8] These adaptations lead to Obstetric Pelvic Floor Disorders.

Obstetric Pelvic Floor Disorders refers to effects of pregnancy and childbirth on anatomy and function of the pelvic floor appearing up to 12 months postpartum. The joint report of International Urogynecological Association (IUGA) and International Continence Society (ICS) mentions the framework for Obstetric Pelvic Floor Disorders. They have involved the following disorders bladder storage symptoms, Postmicturition symptoms, Anorectal & Defecatory symptoms, Pelvic organ prolapse symptoms, Sexual dysfunction symptoms and Lower urinary tract pain.

 Aim: To develop a comprehensive Physiotherapy protocol for Obstetric Pelvic Floor Disorders in Postpartum Women.

Objectives:

To determine the prevalence of Obstetric Pelvic Floor Disorders among Postpartum women.

To provide empirical evidence on physiotherapy management of obstetric pelvic floor disorders and factors influencing treatment in postpartum women.

To develop a Comprehensive Physiotherapy Protocol for Obstetric Pelvic Floor Disorders in Postpartum Women.

 

JUSTIFICATON FOR STUDY:

Obstetric pelvic floor disorders represent a critical area of study due to their impact on women’s health. Current literature tends to focus on specific conditions within this umbrella term, often accompanied by varied terminology. Despite existing management strategies, these disorders remain highly prevalent and seemingly underreported, as the full spectrum of related conditions is not collectively studied. This study aims to address these gaps by determining the overall prevalence of obstetric pelvic floor disorders, investigating the barriers, understanding current management practices, and exploring innovative solutions in patient care.

OUTCOME MEASURES:

Self- made pre-validated questionnaire to determine the prevalence of obstetric pelvic floor disorders

Quality of life questionnaire for obstetric pelvic floor disorders

Methodology

Phase 1: Prevalence Study

Aim: To determine the prevalence of symptoms of Obstetric Pelvic floor disorder in postpartum women.

Objectives:

 To determine the prevalence of Obstetric Pelvic floor disorder in postpartum women

 To identify the risk factors associated to obstetric pelvic floor disorders in postpartum women.

Inclusion Criteria:

  1. Postpartum females in the age group of 18-40 years and within 1 year of childbirth.

Exclusion Criteria:

  1. Patients having symptoms of pelvic floor dysfunction before pregnancy.

 

Phase 2: Qualitative Study- Personal Interview method

Aim: To explore the view of stakeholders on physiotherapy management of obstetric pelvic floor disorders and factors influencing treatment in postpartum women.

Objectives:

Conduct PI with gynecologists to understand their perspective on physiotherapy management, their referral strategy, success rate and the factors which would influence treatment in postpartum women with obstetric pelvic floor disorders.

 Conduct PI with women’s health therapist to understand common management strategies used by them and the factors which would influence treatment in postpartum women with obstetric pelvic floor disorders

 Conduct PI with patients having symptoms of obstetric pelvic floor disorders and understand their knowledge, attitude and practices towards obstetric pelvic floor disorders, perspective towards management strategies and the factors which would influence treatment in postpartum women with obstetric pelvic floor disorders.

 Phase 3: Intervention

Aim: To develop a novel and ingenious Physiotherapy protocol for management of obstetric pelvic floor disorder in postpartum women.

  Objectives:

To study the effect of 6 weeks of management protocol on associated symptoms of obstetric pelvic floor disorder and quality of life in postpartum women.

STATISTICAL ANLAYSIS METHODS INCLUDING SAMPLE SIZE JUSTIFICATION:

Phase 1 :

Descriptive and Interferential statistics of the data obtained.

 

Phase 2:

Qualitative analysis – Personal interview (Gynecologist, Women’s Health Therapist and Women with Obstetric Pelvic Floor Disorders)

Phase 3:

Test for normality for the data

Intragroup and Intergroup analysis to interpret the results

SAMPLE SIZE:

Phase 1: Will be determined by pilot study

Personal Interview: till the saturation point is achieved

Will be calculated after determining prevalence in Phase 1

 

INCLUSION & EXCLUSION :

Phase 1: Postpartum women without any history of pelvic floor disorders prior to pregnancy

Phase 2: Gynaecologist, Women’s Health Therapist (Minimum 6 patients of obstetric pelvic floor disorders in the past 6 months); Patients with symptoms of obstetric pelvic floor disorder

Phase 3: Patients with symptoms of obstetric pelvic floor disorder willing to participate in the intervention

 
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